OSHA
U.S. federal regulation for workplace safety standards
ISO 13485
International standard for medical device quality management systems
Quick Verdict
OSHA mandates US workplace safety through enforced standards and inspections, while ISO 13485 certifies voluntary QMS for medical devices. Companies adopt OSHA for legal compliance and ISO 13485 for global market access and quality assurance.
OSHA
29 CFR 1910 Occupational Safety and Health Standards
Key Features
- Mandates General Duty Clause for recognized serious hazards
- Enforces hierarchy of controls prioritizing engineering solutions
- Codifies performance-based standards in 29 CFR 1910
- Imposes risk-prioritized inspections with civil penalties
- Requires OSHA 300 logs and electronic injury reporting
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Design and development validation requirements
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing controls
- Medical device files and traceability mandates
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
OSHA Details
What It Is
OSHA, the Occupational Safety and Health Administration, created by the OSH Act of 1970, enforces U.S. occupational safety and health standards primarily in 29 CFR 1910 for general industry. Its mission assures safe working conditions nationwide, using performance-based standards, the General Duty Clause (Section 5(a)(1)), and a hierarchy of controls approach.
Key Components
- Subparts A-Z cover walking-working surfaces, PPE, hazardous materials, toxic substances (Subpart Z), emergency plans.
- Over 30 subparts with PELs, medical surveillance, recordkeeping.
- Built on specific standards precedence, General Duty fallback; enforced via inspections, no certification.
Why Organizations Use It
- Mandatory legal compliance under OSH Act prevents penalties up to $165,514.
- Reduces injuries/illnesses, lowers costs, boosts productivity.
- Builds stakeholder trust, enhances reputation via data transparency.
Implementation Overview
- Develop IIPP, hazard assessments, training, engineering controls, OSHA 300 logs.
- Applies to most U.S. employers; state plans vary.
- Ongoing: inspections, electronic ITA submissions, abatement verification.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a certifiable framework for organizations in the medical device lifecycle, emphasizing risk-based controls to ensure devices meet customer and regulatory requirements from design to post-market surveillance.
Key Components
- Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
- Over 20 documented procedures/records required, built on process approach and ISO 9001 compatibility.
- Core principles: traceability, validation, risk management (per ISO 14971), medical device files.
- Third-party certification via accredited bodies with stage audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026), reduces recalls/liabilities.
- Drives operational excellence, supplier control, continual improvement.
- Builds stakeholder trust, competitive edge in regulated markets.
Implementation Overview
- Phased: gap analysis, process design, validation, audits (9–18 months typical).
- Applies to manufacturers, suppliers globally; suits all sizes with tailored exclusions.
- Requires internal audits, management reviews for certification/surveillance.
Key Differences
| Aspect | OSHA | ISO 13485 |
|---|---|---|
| Scope | Workplace safety, health hazards, recordkeeping | Medical device QMS, lifecycle, regulatory compliance |
| Industry | General industry, construction, all US sectors | Medical devices, suppliers, global |
| Nature | Mandatory US regulation, enforced by OSHA | Voluntary certification standard |
| Testing | Inspections, injury logs, no certification | Internal audits, certification body audits |
| Penalties | Civil fines up to $165k, daily abatement | Loss of certification, no direct fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about OSHA and ISO 13485
OSHA FAQ
ISO 13485 FAQ
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